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Wednesday, July 28, 2021

FDA Authorizes Pfizer Vaccine for Children Ages 12-15

The Food and Drug Administration (FDA) in the United States has authorized on May 10 the Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents aged 12 to 15 years.

Acting FDA Commissioner Janet Woodcock described the emergency use authorization for younger teens as “a significant step in the fight against the COVID-19 pandemic.”

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” Woodcock said in a statement.

According to the FDA, the vaccine has met the criteria to extend its use to the age group after authorizing it for those aged 16 years and above last December.

FDA also stated that it based its decision from a clinical trial where 1,131 out of 2,260 participants received the vaccine while the remaining received the placebo shot. No cases were reported among those who received the vaccine.

FDA also said that the most commonly reported side effects from the clinical trial participants include headache, muscle pain, fever, joint pain, and tiredness.

Last week, President Joe Biden announced that his administration was “ready to move immediately” to make 20,000 pharmacy sites across the country prepared to vaccinate the adolescents “as soon as possible,” once the FDA issued the authorization.

The authorization of the vaccine for the age group in the U.S. comes a week after Canada authorized the use of the same vaccine to the same age group, becoming the first country to do so.

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